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510(k) Data Aggregation
K Number
K113402Device Name
SOLOHEALTH STATION
Manufacturer
SOLOHEALTH, INC.
Date Cleared
2012-05-30
(195 days)
Product Code
DXN, DRG, HOX
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
SOLOHEALTH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SoloHealth Station is intended to be used by the general public so that a user can measure his/her own blood pressure and pulse rate and his/her own weight. Additionally, the SoloHealth Station is intended to screen adults for clarity of central vision. SoloHealth Station does not provide a general screening of visual function and does not provide a diagnosis of eye health or other disease. The SoloHealth Station only screens clarity of central vision. Users should consult their personal physicians if they have concerns regarding their eyesight.
Device Description
The SoloHealth Station is an automated system for measuring blood pressure and pulse rate designed to be used by the general public in indoor high-traffic commercial areas. It is completely automatic, and measures blood pressure by the oscillometric method. The user is guided by a series for interactive screen and voice instructions. Additionally, the SoloHealth Station measures weight, screens clarity of central vision, and does a risk factor analysis. Users are advised to consult a physician. Upon completion, data may be stored by the user and accessed via a website or sent via electronic mail to the user.
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